The U.S. Food and Drug Administration today approved Tecentriq (atezolizumab) to treat the most common type of bladder cancer, called urothelial carcinoma. This is the first product in its class (PD-1/PD-L1 inhibitors) approved to treat this type of cancer.
Category Archives: Drug Safety Information Podcasts
FDA issues rule for data collection of antimicrobial sales and distribution by animal species
The U.S. Food and Drug Administration (FDA) finalized a rule today that revises its annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in animals intended for human consumption or food-producing animals. Companies are now required to provide estimates of sales broken down by major food-producing species (cattle, swine, chickens and turkeys) in addition to the overall estimates they already submit on the amount of antimicrobial drugs they sell or distribute for use in food-producing animals.
FDA reminds health care professionals not to use drug products intended to be sterile from Medaus
FDA reminds health care professionals not to use drug products intended to be sterile from Medaus
FDA takes significant steps to protect Americans from dangers of tobacco through new regulation
FDA takes significant steps to protect Americans from dangers of tobacco through new regulation
Federal court orders rice noodle company to stop selling products until it complies with food safety regulations
On April 27, 2016, the United States District Court for the Northern District of California entered a consent decree of permanent injunction against Kun Wo Food Products Inc., located in San Francisco, and its co-owners, Zi Xing Liu and Zi Chen Liu (“Kun Wo”), after the U.S. Food and Drug Administration documented violations of federal food safety laws. The U.S. Department of Justice handled the case on behalf of the FDA.
FDA launches public education campaign to prevent and reduce tobacco use among LGBT young adults
The U.S. Food and Drug Administration today announced the launch of a historic public education campaign aimed at preventing and reducing tobacco use among lesbian, gay, bisexual and transgender (LGBT) young adults ages 18-24. Of the more than 2 million LGBT young adults in the U.S., more than 800,000 smoke occasionally. The “This Free Life” campaign is designed to specifically reach the occasional or “social” smokers in the LGBT community to help prevent tobacco-related disease and the loss of tens of thousands LGBT lives to tobacco use each year.
Federal judge enters order of permanent injunction against Paul W. Franck
The U.S. Food and Drug Administration today announced that U.S. District Judge Carlos E. Mendoza entered an order of permanent injunction against Paul W. Franck of Ocala, Florida. According to the complaint filed with the consent decree, Franck manufactured and distributed drug products that were adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The U.S. Department of Justice brought the action on behalf of the FDA.
FDA approves first drug to treat hallucinations and delusions associated with Parkinson’s disease
The U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.
FDA approves first generic Crestor
The U.S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets for the following uses
FDA proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior
The U.S. Food and Drug Administration today announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling.